Haag-Streit USA Inc Recall 89176
Description: OCT-Camera 211 01 A3; Running software iOCT-Control 3 v1.4
Haag-Streit USA Inc Recall 89176 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-0478-2022 |
| Event ID | 89176 |
| Event Description | OCT-Camera 211 01 A3; Running software iOCT-Control 3 v1.4 |
| Product Type | Devices |
| Distribution | US Nationwide distribution in the states of OH, IN. |
| Quantity | 3 |
| Recall Reason | Malfunction of the automatic laser beam shut-off, the OCT unit might not recognize whether the laser beam is safely switched off |
| Device Classification | 20220119 |
| Device Code Info | Serial no. 0157, 0158 & 0171 |
| Center Classification Date | 20220110 |
| Recall Initiation Date | 20211103 |
| Recalling Firm | Haag-Streit USA Inc |
| Initial Notification | Letter |
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